Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia

July 30, 2019 updated by: Xuanwu Hospital, Beijing
The purpose of this research is to compare the effectiveness of a training protocol integrating Brain-machine Interfaces, Visuo-tactile feedback and Assisted Locomotion (referred to as the Walk Again Neurorehabilitation protocol, or WANR), with classical physiotherapy training for patients with chronic complete paraplegia due to spinal cord injury.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Discomplete spinal cord injury;
  • 2. Traumatic etiology;
  • 3. American Spinal Injury Association Impairment Scale(ASIA) A grade;
  • 4. The level of SCI in T9-T12;
  • 5. ≥12 months post injury;
  • 6. Considered independents to perform daily life activities: feeding, dressing, capability with wheelchair;
  • 7. Emotional stability;

Exclusion Criteria:

  • 1. Absence of SCI, or presence of multi-segmental injury;
  • 2. SCI non-traumatic etiology;
  • 3. Age<18 years or Age>60 years;
  • 4. Emotional instability;
  • 5. Unavailable time to join the protocol activities;
  • 6. Already enrolled in other research protocol;
  • 7. Acute or chronic decompensated comorbidities (e.g. Hypertension, Diabetes, cardiomyopathy, chronic respiratory insufficiency, chronic renal insufficiency, hepatopathy, or any other neurological disorders besides the SCI);
  • 8. Alcohol/drugs abuse and dependence;
  • 9. Psychiatric disorders (exception: treated depression);
  • 10.Cognitive deficit; visual deficit; auditory deficit;
  • 11. Incapacitating pain;
  • 12. Pregnancy;
  • 13. Presence of limb amputations (exception: hand distal phalanges);
  • 14. Peripheral neuropathy associated (e.g.: brachial plexus injury, carpal tunnel syndrome);
  • 15. Muscle injury associated (e.g. myotendinous rupture, burning injury, muscle-compartment syndrome);
  • 16. Neuromuscular disease associated (ex: myopathy) or lower limb fractures within the past six months;
  • 17. Movement disorders(e.g. ataxia);
  • 18. Use of medication that can negatively impact on neurological/motor recovery;
  • 19. Presence of joint deformities, presence of fractures;
  • 20. Lower limb spasticity MAS (Modified Ashworth Scale)>2;
  • 21. Pressure ulcer: considering grade 3 or 4, injury size and body location;
  • 22. Cephalic metallic /magnetic implants (exception: MRI compatible implants);
  • 23. Presence of cardiac or neural pacemaker;
  • 24. Use of devices/tubes: tracheostomy, gastrostomy, nasogastric, long-term bladder catheterization, cystostomy, colostomy, totally implanted catheter system, arteriovenous dialysis fistula;
  • 25. Severe osteoporosis (Tscore>-4);
  • 26. Syringomyelia;
  • 27. Lokomat or ZeroG training within the prior 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: WANR protocol
Including training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion
Training integrating virtual-reality avatar driven by a brain-machine interface, with tactile feedback through patient's forearms, and assisted locomotion, for neurorehabilitation of SCI patients.
ACTIVE_COMPARATOR: Classical physiotherapy protocol
Training with classical physiotherapy protocol
Stretching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of Lower limbs Motor function: ASIA motor score (LEMS) at the ending time point
Time Frame: After nine-months of training
The LEMS evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function) for 5 lower extremity muscle groups with a 50-point maximum (25 per side)
After nine-months of training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of nociception improvement: ASIA pin-prick sensory score
Time Frame: After nine-months of training

Testing of a key point in each of the 28 dermatomes (from C2 to S4-5) on the right and left sides of the body that can be readily located in relation to bony anatomical landmarks. At each of these key points, sensation of pin prick is examined:

Appreciation of pin prick sensation at each of the key points is separately scored on a three-point scale, with comparison to the sensation on the patients' cheek as a normal frame of reference:

0 = absent

1= altered (impaired or partial appreciation, including hyperesthesia)

2 = normal or intact (similar as on the cheek)

NT = not testable

The maximum scale is 112

After nine-months of training
Improvement of Walking index for SCI (WISCI)
Time Frame: After nine-months of training
The subject is observed by the trained personnel and the WISCI level is recorded on the scale of 0 to 20 at baseline (Baseline WISCI). The subject is observed again at the defined interval (Interval WISCI). The change in score is calculated by subtracting the baseline WISCI from the Interval WISCI, which equals the change in WISCI (Changed WISCI).
After nine-months of training
Change of WHO-QoL bref
Time Frame: After nine-months of training
The WHOQOL-BREF questionnaire contains two items from the Overall QOL and General Health and 24 items of satisfaction that divided into four domains. Raw domain scores for the WHOQOL were transformed to a 4-20 score according to guidelines
After nine-months of training
Change of post-void residual urine
Time Frame: After nine-months of training
Usually, the value is less than 50 ml. A post-void residual urine greater than 50 ml is a significant amount of urine and increases the potential for recurring urinary tract infections. In adults older than 60 years, 50-100 ml of residual urine may remain after each voiding because of the decreased contractility of the detrusor muscle
After nine-months of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Guo-Guang Zhao, M.D., Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2019

Primary Completion (ANTICIPATED)

March 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (ACTUAL)

June 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • XW-[2019]-023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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